documents and documentation (general)

  1. W

    Documentation - Use of Addendum vs Amendment

    Hi all, Our procedure has the following definitions: Addendum: additional pages or sections that are added to an existing document Amendment: minor changes to pages of an existing document, correcting an error in the original document, or supplying supplementary information to clarify the...
  2. J

    Just Venting - Do you refer directly to MDR or you just refer to SOP's?

    I recently started working for a small med device setup. In my previous company ( giant med device) we would have one SOP with all the information and references directly to the MDR or ISO's. In my new company, they spread everything out and have SOP's and documents for everything. For example...
  3. C

    Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update?

    Good Morning! We have almost everything completed in our ISO folder for our upcoming audit next month. My questions is do we need to make a new OFI for each document/form we update in our ISO folder? Ex: we updated our recruiting and on-boarding checklist, do we need to make an OFI for this or...
  4. Q

    How to efficiently and compliantly reference external standards/regulations

    I am looking for advice on how to efficiently and compliantly reference external standards/regulations. I work for a small medical device company and we are rapidly expanding into new markets and with that we are now governed by over 100 standards/regulations. Historically we would cite 21CFR...
  5. Marcelo Antunes

    Informational BSI – MDR Documentation Submissions Best Practices Guidelines

    Interesting read from BSI – MDR Documentation Submissions Best Practices Guidelines Continue reading...
  6. R

    DMR or Manufacturing Documentation - How detailed does the documentation have to be?

    Hello everyone, For those who have had experience assembling DMRs, with respect to manufacturing instructions, how detailed does the documentation have to be so as not to give away proprietary information. For example, in machine assembly drawings or a manufacturing process flow chart or...
  7. S

    Is Adobe Sign - E-signature for QMS documents - 21 cfr part 11 compliant?

    Hi everyone, I would like clarification on the use of Adobe Sign to electronically sign QMS documents that is also 21 cfr part 11 compliant. Does anyone have experience with this? The link is this: Adobe Sign for Microsoft - Word/PowerPoint Add-in E-sign documents online, secure e-signature...
  8. T

    Effective Date on Documents

    All, Please correct me if I'm wrong - within 21 CFR 820, ISO 13485:2016, and the MDD, I cannot find that having the effective date on a document is required. All that is required is that the document was reviewed and approved, has an identifier (e.g. name, number, revision level, etc.)...
  9. N

    GDP - Having to provide a reason when writing N/A?

    Hello All - Apparently, our company has not been following GDP as closely as it should. But we are putting the training in place now and hope it goes smoothly. While going on this training, it states that the person completely a form, much initial, date and provide a reason when...
  10. W

    Interview question - Quality work documents

    Hi everyone, I will have an on-site interview next week. My employer has requested that I need to bring a "quality work documents to demonstrate my writing skills". I'm not sure what is "quality work documents" mean? It should be a document related to quality or it should be a formal and...
  11. P

    Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis

    We are an ASME Pressure Vessel manufacturing and repair service company in the petrochemical arena. Recently we have decided to improve our QMS to include a formal NCR, CAR and Root Cause analysis program. MY back ground is in the field installation but have had some limited training in the...
  12. V

    ISO 9001:2015 Implementation Packages

    Hi, QMS consultant looking for recommendations on ISO 9001:2015 Implementation Packages/Templates. I have a manufacturing/repair depot client starting from scratch. I have used these packages before as a starting point on other implementation projects to save a lot of admin work with good...
  13. N

    How is documentation affected moving to an electronic system?

    We are transitioning from paper based to an ERP system. Our controlled documents are being implemented into the system but they will appear as fields, rather an documents. They will all have change history recorded and revision levels. In the past, I was required to keep the old revisions...
  14. C

    ISO 9001 2015 Documentation for Engineering and Design

    Hello Everyone, Could you help clear out my confusion about where do the different design documents such as sizing arrangements, mathematical calculations, dimensioning, configurations overview concept documents, etc. , fall within the pyramid hierarchy of documents of a QMS (i.e. Policy...
  15. B

    The impact of IoT in ISO documentation

    A procedure list the things you need to do sequencially in a routine process to ensure that everything is done and nothing gets neglected or outright forgotten. A work instruction tells you how to do something. However, Artificial Intelligence (AI) has already been applied to highly repeatable...
  16. G

    Procedure Creation specifically for dimensional (caliper, micrometer, dti)

    Hi, I'm about to create our own internal procedure,how do I approach a procedure specifically for dimensional (caliper, micrometer,dti) should I check the OEM or check the British Standards? And would it be a general procedure for all, even though we're applying for range of up to 24inches...
  17. S

    Are 2 Hard Copies of Procedures and Instructions Required?

    Hi ISO 13485 community, How many hard copies of our QMS procedures should we keep around in the company? In the past, the regulatory department in charge ensured that there were at least 2 hard copies; one master procedure and one copy of it kept in another location. I understand the reason...
  18. S

    Integrating a Contract Manufacturer's documentation into our Quality System

    Hi everyone, My company recently brought the manufacturing process in house from the contract manufacturer. In our DMR, I have noticed that there is a lot of documentation from the contract manufacturer including their quality plan and DHR templates. What I don't know is how the contract...
  19. I

    Engineering Drawing = Record or Document?

    Hi All, Preface; I'm not a QS Manager or Quality Engineer, but have done a fair amount of research and self learning to push the organization I'm in towards getting ISO 13485 certification. Can someone please tell me if a completed engineering drawing is handled as a record or a document...
  20. L

    Documentation Planning - IEC 62304 Clause 5.1.8

    Int the clause 5.1.8, it is asked to include for each document or type of document the a) Title, name or naming convention (I this point I just made reference to my configuration management plan) b) Purpose c) Intended audience of document d) Procedures and responsibilities for...
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